# K020985: Modified TFX Medical Safety Needle with Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Tfx Medical, Inc.
- Decided: Jun 25, 2002 after 90 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K851140 (1985). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851140: Teleflex Medical Introducer Needle, Teleflexmedical, Inc. (1985) Summary page 1.
- K895024: Punctur-Guard (TM) Blood Collection Needle, Bio-Plexus, Inc. (1990). Our reading of the summary gave K895034, FDA’s number for Buckys Models Ymb-15A, Ymb-15B and Ymb-15C (Yamato Medical Corp.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “The PUNCTUR-GUARD Blood Collection Needle of Bio-Plexus, Inc.”.
- K912047: Wilson-Cook Russell Gastrostomy Kit, Wilson-Cook Medical, Inc. (1991) Summary page 1.
- K920908: Over the Needle Splitable Catheter Assembly Type 1, Teleflexmedical, Inc. (1992) Summary page 1.
- K000665: TFX Medical Safety Needle with Introducer, Tfx Medical, Inc. (2000) Summary page 2.
- (no number) The COOK8 Gastric Port System: named in the summary without a submission number
- (no number) The COOK8 Edelman Gastrostomy Tray: named in the summary without a submission number

## Indications for use
The Modified TFX Medical Safety Needle with Introducer is intended to be used for guidewire introduction during gastrointestinal procedures. such as PEG (Percutaneous Endoscopic Gastrostomy), PEJ (Percutaneous Endoscopic Jejunostomy) or other endoscopic gastrointestinal procedures requiring placement of a guidewire.

Source page: https://510kreport.com/device/K020985
Methodology: https://510kreport.com/methodology